Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091648
Company: NATCO
Company: NATCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET;ORAL | Discontinued | None | No | No |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET;ORAL | Discontinued | None | No | No |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/25/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091648Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/26/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |